AR2-C2

Clinical strategy and legal representative services

Munich MedTech - Regulatory Consulting

15.09.2023 Clinical strategy and legal representative services A clear clinical evidence-generating strategy for both pre- and post-marketing phases is necessary to demonstrate the safety and effectiveness of the device. How to set up an efficient clinical strategy? What should be included in the clinical evaluation? We possess the necessary know-how and experience to help you set those up, support you in finding European cooperation partners, and act as your legal representative during those studies. contact us Back to services

Regulatory strategy / Intended use and classification support

Munich MedTech - Regulatory Consulting

14.09.2023 Regulatory strategy / Intended use and classification support: It is not always clear if a product is a medical device, a medicinal product, or something else and if it is a medical devices, what risk class. We help you define your product and its optimal route to compliance, guide you through the certification process, and assist in your  entrance into the European market. contact us Back to services

Technical Documentation

Technical Documentation

19.08.2023 Technical Documentation: Do you need help setting up the technical documentation or have doubts about your strategy to demonstrate the safety and efficiency of the device? We have the expertise to support you with all your questions and dilemmas and prepare you for the scrutiny by notified bodies or authorities. contact us Back to services

Quality Management System (QMS)

Quality Management System

12.09.2023 Quality Management System (QMS): Your quality management system must correspond to type of product and be ready for fierce auditing. We will be happy to provide support and training on all your QMS-related topics. contact us Back to services

Marketing Strategy / Reimbursement system in Europe

Reimbursement system

19.08.2023 Marketing Strategy / Reimbursement system in Europe: Tailored to the destination market healthcare system is essential for your success. We can help you adjust your strategy to the European market reality. contact us Back to services

Authorized Representative / Communication with the notified bodies

Communication with the notified bodies

11.09.2023 Authorized Representative / Communication with the notified bodies: Might be a challenge We can support you through the complete process: starting from the initial contract, providing support during submissions and audits, and offering authorized representative services. contact us Back to services